Utilize pilot production methods and materials together with DOE and FMEA for proof of concept.

Using SolidWorks, develop innovative designs, assign realistic specifications, account for assembly tolerances within the device and work within vendor process capabilities.

Work seamlessly within multi-user SolidWorks environment for file sharing and revision control.

Lead activities related to test and evaluation of prototypes and finished medical devices.

Coordinate internal and external design program resources as well as vendors.

Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal, international and company safety regulations, policies and procedures.

Required Qualifications :

BS Mechanical or Biomedical Engineering

Minimum 3 years experience with disposable medical device design.

Project management experience.

Experience with SolidWorks.

Expertise in Design for Assembly (DFA) and Design for Manufacturability (DFM).

Experience in plastic materials and injection molding techniques.

Knowledge of medical device sterilization methods and its effect on materials and packaging methods.

Demonstrated experience or knowledge with all phases of the Design Control and Validation processes in the context of FDA and ISO 13485 regulations and understanding of disciplined product development processes, regulatory and quality requirements for medical products.

A clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ, with experience in the implementation of these activities.